In light of escalating COVID-19 cases and hospitalizations, the U.S. Food and Drug Administration (FDA) has granted approval for the modified vaccines developed by Moderna and Pfizer/BioNTech. Both companies have confirmed their vaccines’ potency against the dominant EG.5 strain currently circulating in the U.S.
The next step involves an independent expert body, the Advisory Committee on Immunization Practices, which advises the CDC, in evaluating the vaccines’ safety and efficacy. Pending the CDC director’s approval, the vaccines will be released for public use.
With the urgency mounting due to the surge in COVID-19 and potential threats from other respiratory viruses this fall and winter, the advisory body is set to convene promptly. The revamped vaccines might soon be rolled out at select healthcare centers and pharmacies.
Dr. Peter Marks, heading the FDA’s Center for Biologics Evaluation and Research, stressed the essential nature of vaccination. He assured the public of the vaccines’ safety and urged eligible individuals to get vaccinated.
While recent data depicts a spike in infections, Dr. Dan Barouch highlighted that severe disease and fatality rates remain comparatively lower than in previous waves.
With the current spike in cases, Pfizer’s CEO, Albert Bourla, underscored the gravity of the FDA’s decision. He pointed out that nearly everyone aged six months or more in the U.S. could now receive this season’s vaccine.
The revised vaccines cater to individuals 12 and above, with emergency permissions for those between six months to 11 years. U.S. authorities have discontinued the use of the initial bivalent Moderna and Pfizer/BioNTech vaccines.
As per the FDA, unvaccinated infants and toddlers (six months to four years) can get either three Pfizer/BioNTech doses or two Moderna shots. Vaccination schedules for previously vaccinated individuals differ. For those aged five and above, one updated vaccine dose is advised two months post their latest shot.
Moderna’s CEO, Stéphane Bancel, accentuated the vaccines’ role in shielding citizens during the high-risk virus season.
The newly adjusted mRNA vaccines aim to tackle the XBB.1.5 Omicron subvariant and related strains.
Anticipating future changes in the virus, the FDA foresees possible annual updates for the COVID-19 vaccines, mirroring the flu vaccine protocol.
Dr. Ugur Sahin from BioNTech expressed the company’s intent to keep the vaccine relevant against the evolving virus strains.
The revamped vaccines will be administered as a single dose and provided free for those in need.
Novavax’s revised vaccine awaits FDA approval, targeted for those 12 and above.
The Affordable Care Act ensures that most insured individuals receive the vaccines without co-pays. The CDC’s Bridge Access Program, set to end in December 2024, facilitates free vaccinations for those without adequate insurance coverage.
This rollout marks the first time vaccines are offered via the commercial market, with a single dose potentially priced between $110 to $130 for adults, as per a recent Pfizer investor call.